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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AMS SLING SYSTEM; MESH SURGICAL FOR STRESS URINARY INCONTINENCE MALE
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BOSTON SCIENTIFIC CORPORATION AMS SLING SYSTEM; MESH SURGICAL FOR STRESS URINARY INCONTINENCE MALE Back to Search Results
Model Number UNK-P-SLING-MENS
Device Problem Insufficient Information (3190)
Patient Problems No Known Impact Or Consequence To Patient (2692); Insufficient Information (4580)
Event Date 10/26/2020
Event Type  Injury  
Event Description
It was reported that an unspecified sling was implanted on an unspecified date.An artificial urinary sphincter (aus) device was later implanted due to unspecified reasons.
 
Manufacturer Narrative
Additional information provided in b5 (describe event/problem) - additional information received states the previous sling was not a boston scientific sling.It was an argus male sling.
 
Event Description
It was reported that an unspecified sling was implanted on an unspecified date.An artificial urinary sphincter (aus) device was later implanted due to unspecified reasons.Additional information received states the previous sling was not a boston scientific sling.It was an argus male sling.
 
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Brand Name
AMS SLING SYSTEM
Type of Device
MESH SURGICAL FOR STRESS URINARY INCONTINENCE MALE
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
10700 bren road w
minnetonka MN 55343
MDR Report Key11131425
MDR Text Key225514508
Report Number2183959-2020-06298
Device Sequence Number1
Product Code OTM
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
Type of Report Initial,Followup
Report Date 02/25/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model NumberUNK-P-SLING-MENS
Device Catalogue NumberUNK-P-SLING-MENS
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 12/11/2020
Initial Date FDA Received01/07/2021
Supplement Dates Manufacturer Received01/31/2021
Supplement Dates FDA Received02/25/2021
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age75 YR
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